NCT00752869

Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement

Dutasteride in Men Receiving Testosterone Therapy: Impact on Serum PSA, Testosterone, DHT Levels and Prostate Volume: "Implications for Prostate Safety"

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: The Miriam Hospital · Academic / Other
• Sex: Male
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a study using two FDA approved medications: Testosterone and the study medication, Dutasteride (Avodart 0.5mg/day). Half of the subjects will receive dutasteride and half will receive a placebo. The study medication will be taken for 12 months. The subjects participating in the study are men who are already taking their own testosterone supplement because they have low testosterone levels which may cause them to experience sexual function difficulties, have fatigue or other symptoms. Testosterone can have an adverse effect of causing an enlarged prostate (Benign Prostatic Hypertrophy) (BPH). Dutasteride (Avodart) is an approved medication used to decrease the prostate size, prevent urinary symptoms and reduce the risk of surgery. The researchers would like to see if by taking dutasteride and testosterone at the same time they can prevent the adverse effects of testosterone and at the same time get the positive benefits of testosterone. There will be 6 scheduled visits for the study and 2 diagnostic tests called a TRUS (TransRectal UltraSound), to evaluate prostate size. The six visits at will include consenting, blood work, two sexual function questionnaires, a physical examination, physical measurements, study medication teaching and dispensing of study medication.

Detailed description

Termination criteria 1. Serum AST or ALT \> 3 times ULN 2. Total serum bilirubin \> 1.5 times ULN * no study termination of a patient with documented Gilberts disease for an isolated bilirubin elevation unless it exceeds 2.5x the upper limit of normal. 3. Hematocrit \> 55% 4. Subject experiences any unacceptable or intolerable adverse effect. 5. Subject is non-compliant with the study protocol. 6. Subject needs to take any medication that would interfere with study measurements 7. Subject develops prostate or breast cancer

Conditions

• Hypogonadism

Interventions

Type	Name	Description
DRUG	dutasteride	0.5mg by mouth one time per day for 1 year
DRUG	placebo	one tablet per day for 1 year

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2008-09-16
• Last updated: 2013-02-26

Locations

2 sites across 1 country: United States